KIDS ANTISEPTIC WIPES- antiseptic wipes alcohol free cloth 
Valley of the Sun Cosmetics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antiseptic Wipes

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

Antiseptic Wipes are used to help reduce bacteria that potentiallyy can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do not use

When using this product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

If irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of babies

If swallowed, get medical help or contact a poison Control Center right away

Directions

Other information

Inactive ingredients

Water, glycerin, aloe barbadensis (aloe vera) leaf extract, hydrogen peroxide, tocopheryl acetate (Vitamin E), propylene glycol, peg-60 hydrogenated castor oil, phenoxyethanol

Package Label

Kids Antiseptic 80 wipes, 454g, NDC: 76523-098-090

Label Product Picture Front

KIDS ANTISEPTIC WIPES 
antiseptic wipes alcohol free cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76523-098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.3 g  in 100 g
WATER (UNII: 059QF0KO0R) 97.14 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 1.45 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.3 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.15 g  in 100 g
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 g  in 100 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 g  in 100 g
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) 0.4 g  in 100 g
Product Characteristics
Colorwhite (White canister with blue cap) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76523-098-80454 g in 1 CANISTER; Type 0: Not a Combination Product11/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/13/2020
Labeler - Valley of the Sun Cosmetics LLC (176470664)
Registrant - Valley of the Sun Cosmetics LLC (176470664)
Establishment
NameAddressID/FEIBusiness Operations
Valley of the Sun Cosmetics LLC176470664manufacture(76523-098)

Revised: 11/2020
Document Id: b407c9c8-1bbb-cfa6-e053-2a95a90ab310
Set id: b407c9c8-1bba-cfa6-e053-2a95a90ab310
Version: 1
Effective Time: 20201113
 
Valley of the Sun Cosmetics LLC